EP1305021A4 - RAPID EXPANSION COMPOSITION FOR GASTRIC RETENTION AND REGULATED RELEASE OF THERAPEUTIC AGENTS, AND DOSAGE FORMS COMPRISING THE SAME - Google Patents

RAPID EXPANSION COMPOSITION FOR GASTRIC RETENTION AND REGULATED RELEASE OF THERAPEUTIC AGENTS, AND DOSAGE FORMS COMPRISING THE SAME

Info

Publication number
EP1305021A4
EP1305021A4 EP01946709A EP01946709A EP1305021A4 EP 1305021 A4 EP1305021 A4 EP 1305021A4 EP 01946709 A EP01946709 A EP 01946709A EP 01946709 A EP01946709 A EP 01946709A EP 1305021 A4 EP1305021 A4 EP 1305021A4
Authority
EP
European Patent Office
Prior art keywords
composition
dosage forms
therapeutic agents
controlled release
forms including
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP01946709A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP1305021A1 (en
Inventor
Moshe Fleshner-Barak
E Itzhak Lerner
Vered Rosenberger
Mazal Dahan
Yisrael Imakov
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Teva Pharmaceutical Industries Ltd
Original Assignee
Teva Pharmaceutical Industries Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Teva Pharmaceutical Industries Ltd filed Critical Teva Pharmaceutical Industries Ltd
Publication of EP1305021A1 publication Critical patent/EP1305021A1/en
Publication of EP1305021A4 publication Critical patent/EP1305021A4/en
Withdrawn legal-status Critical Current

Links

Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B82NANOTECHNOLOGY
    • B82BNANOSTRUCTURES FORMED BY MANIPULATION OF INDIVIDUAL ATOMS, MOLECULES, OR LIMITED COLLECTIONS OF ATOMS OR MOLECULES AS DISCRETE UNITS; MANUFACTURE OR TREATMENT THEREOF
    • B82B3/00Manufacture or treatment of nanostructures by manipulation of individual atoms or molecules, or limited collections of atoms or molecules as discrete units
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0065Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/66Phosphorus compounds
    • A61K31/662Phosphorus acids or esters thereof having P—C bonds, e.g. foscarnet, trichlorfon
    • A61K31/663Compounds having two or more phosphorus acid groups or esters thereof, e.g. clodronic acid, pamidronic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/14Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16Anti-Parkinson drugs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/28Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B82NANOTECHNOLOGY
    • B82YSPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
    • B82Y15/00Nanotechnology for interacting, sensing or actuating, e.g. quantum dots as markers in protein assays or molecular motors

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hematology (AREA)
  • Nanotechnology (AREA)
  • Epidemiology (AREA)
  • Crystallography & Structural Chemistry (AREA)
  • Urology & Nephrology (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Nutrition Science (AREA)
  • Cell Biology (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Physiology (AREA)
  • Psychiatry (AREA)
  • Food Science & Technology (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Hospice & Palliative Care (AREA)
  • Manufacturing & Machinery (AREA)
  • Psychology (AREA)
EP01946709A 2000-06-23 2001-06-22 RAPID EXPANSION COMPOSITION FOR GASTRIC RETENTION AND REGULATED RELEASE OF THERAPEUTIC AGENTS, AND DOSAGE FORMS COMPRISING THE SAME Withdrawn EP1305021A4 (en)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US21383200P 2000-06-23 2000-06-23
US213832P 2000-06-23
US21711000P 2000-07-10 2000-07-10
US217110P 2000-07-10
US22321200P 2000-08-04 2000-08-04
US223212P 2000-08-04
PCT/US2001/020134 WO2002000213A1 (en) 2000-06-23 2001-06-22 Rapidly expanding composition for gastric retention and controlled release of therapeutic agents, and dosage forms including the composition

Publications (2)

Publication Number Publication Date
EP1305021A1 EP1305021A1 (en) 2003-05-02
EP1305021A4 true EP1305021A4 (en) 2009-09-23

Family

ID=27395915

Family Applications (1)

Application Number Title Priority Date Filing Date
EP01946709A Withdrawn EP1305021A4 (en) 2000-06-23 2001-06-22 RAPID EXPANSION COMPOSITION FOR GASTRIC RETENTION AND REGULATED RELEASE OF THERAPEUTIC AGENTS, AND DOSAGE FORMS COMPRISING THE SAME

Country Status (11)

Country Link
EP (1) EP1305021A4 (ja)
JP (1) JP2004501190A (ja)
KR (1) KR20030013460A (ja)
AU (2) AU2001268722B8 (ja)
CA (1) CA2412490A1 (ja)
CZ (1) CZ2003199A3 (ja)
EA (1) EA200300046A1 (ja)
HU (1) HUP0301465A3 (ja)
IL (1) IL153497A0 (ja)
MX (1) MXPA02012793A (ja)
WO (1) WO2002000213A1 (ja)

Families Citing this family (46)

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US7608640B2 (en) 1999-03-02 2009-10-27 Jallal Messadek Glycine betaine and its use
WO2003015745A1 (en) * 2001-08-16 2003-02-27 The State Of Oregon Acting By And Through The State Board Of Higher Education On Behalf Of Oregon State University Expandable gastric retention device
BE1015608A6 (fr) 2003-07-15 2005-06-07 Messadek Jallal Traitement des arterites.
US7094427B2 (en) * 2002-05-29 2006-08-22 Impax Laboratories, Inc. Combination immediate release controlled release levodopa/carbidopa dosage forms
US20030224045A1 (en) * 2002-05-29 2003-12-04 Chien-Hsuan Han Combination immediate release sustained release levodopa/carbidopa dosage forms
WO2004091601A1 (fr) * 2003-04-17 2004-10-28 Jallal Messadek Formulations orales flottantes pour la liberation controlee de la betaine
JP2007509146A (ja) * 2003-10-20 2007-04-12 テバ ファーマシューティカル インダストリーズ リミティド レボドーパの持続効果のための組成物及び投与形
JP2005132803A (ja) * 2003-10-31 2005-05-26 Ono Pharmaceut Co Ltd 胃内滞留固形剤
TW200533391A (en) 2004-03-25 2005-10-16 Sun Pharmaceutical Ind Ltd Gastric retention drug delivery system
FR2874325B1 (fr) * 2004-08-19 2006-10-20 Sanofi Synthelabo Composition pharmaceutique sous forme de comprime a residence gastrique contenant de l'alfuzosine
WO2006050581A2 (en) 2004-11-10 2006-05-18 Jallal Messadek Betaine as agent against arthropod - or mosquito -borne diseases
EP2242489A1 (en) 2005-02-15 2010-10-27 Jallal Messadek Combination therapeutic compositions and method of use
CA2650556A1 (en) 2005-04-27 2006-11-02 Jallal Messadek Insulins combinations
NL2000281C2 (nl) 2005-11-02 2007-08-07 Pfizer Prod Inc Vaste farmaceutische samenstellingen die pregabaline bevatten.
ZA200810834B (en) * 2006-05-31 2010-03-31 Solvay Pharm Gmbh Long term 24 hour intestinal administration of levodopa/carbidopa
EP1872775A1 (en) * 2006-06-29 2008-01-02 Polichem S.A. Use of a hydrophilic matrix comprising a polyacrylic acid derivative, a cellulose ether and a disintegrant for the manufacture of a medicament for treating female genital disorders
PE20080669A1 (es) * 2006-09-08 2008-07-18 Drugtech Corp Composicion de liberacion sostenida que comprende levodopa
BRPI0622039B1 (pt) * 2006-09-26 2020-11-10 Plensat, Llc dispositivos gástricos ingeríveis de qualidade alimentícia
WO2008087882A1 (ja) 2007-01-15 2008-07-24 Kissei Pharmaceutical Co., Ltd. 胃内滞留型レボドパ徐放性製剤
KR20080076382A (ko) * 2007-02-15 2008-08-20 (주)아모레퍼시픽 실로스타졸의 제어방출 제제 및 그 제조방법
DE102007026037A1 (de) * 2007-06-04 2008-12-11 Lts Lohmann Therapie-Systeme Ag Gastroretentives System mit Alginat-Körper
US20090028941A1 (en) * 2007-07-27 2009-01-29 Depomed, Inc. Pulsatile gastric retentive dosage forms
EP2306823A4 (en) 2008-06-30 2012-09-26 Tocagen Inc FORMULATIONS OF 5-FLUOROCYTOSINE AND ITS USES
US9161911B2 (en) * 2008-08-15 2015-10-20 Depomed, Inc. Gastric retentive pharmaceutical compositions for treatment and prevention of CNS disorders
CA2742680C (en) * 2008-11-07 2013-12-31 Samyang Corporation Pharmaceutical compositions for release control of methylphenidate
WO2012093974A1 (en) * 2011-01-06 2012-07-12 Mahmut Bilgic Improved bisphosphonate formulations
CN103385871B (zh) * 2012-05-07 2017-06-23 新疆医科大学 复方左旋多巴微囊漂浮片
WO2013183058A2 (en) 2012-06-07 2013-12-12 Tulip Medical Ltd. Expanded device
WO2014174388A1 (en) * 2013-03-29 2014-10-30 Wockhardt Limited Modified release pharmaceutical compositions of methylphenidate or salts thereof
JP6204141B2 (ja) * 2013-04-22 2017-09-27 テイカ製薬株式会社 口腔内速崩壊性固形製剤用組成物
US10994013B2 (en) 2013-04-24 2021-05-04 Temple University—Of the Commonwealth System of Higher Education Solid dosage form containing arabinogalactan
EP3054929B1 (en) 2013-10-07 2020-08-05 Impax Laboratories, LLC Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof
US10987313B2 (en) 2013-10-07 2021-04-27 Impax Laboratories, Llc Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof
ES2926480T3 (es) * 2013-12-05 2022-10-26 Epitomee Medical Ltd Dispositivos y sistemas retentivos para la liberación in situ de principios activos farmacéuticos
AU2016225052B2 (en) * 2015-02-27 2021-07-08 Cingulate Therapeutics LLC Tripulse release stimulant formulations
JP6823539B2 (ja) * 2017-05-26 2021-02-03 株式会社ファンケル 胃内滞留性錠剤
EP3648747B1 (en) 2017-06-16 2022-09-07 Amneal Complex Products Research LLC Gastroretentive dosage forms for sustained drug delivery
US10987311B2 (en) 2017-06-16 2021-04-27 Kashiv Specialty Pharmaceuticals, Llc Extended release compositions comprising pyridostigmine
US10588863B2 (en) 2017-06-16 2020-03-17 Kashiv Biosciences, Llc Extended release compositions comprising pyridostigmine
JP7048770B2 (ja) 2018-06-18 2022-04-05 アムニール コンプレックス プロダクツ リサーチ エルエルシー ピリドスチグミンを含む持続放出組成物
DK3628004T3 (da) 2018-06-27 2021-12-20 Amneal Complex Products Res Llc Selvregulerende osmotiske mave-tarm tilbageholdende leveringssystemer til lægemiddel
JP7044649B2 (ja) * 2018-06-28 2022-03-30 株式会社ファンケル 胃内浮遊錠剤
CA3139217A1 (en) * 2019-05-14 2020-11-19 Clexio Biosciences Ltd. Treatment of nocturnal symptoms and morning akinesia in subjects with parkinson's disease
US11986449B2 (en) 2020-12-22 2024-05-21 Amneal Pharmaceuticals Llc Levodopa dosing regimen
US11571402B2 (en) * 2021-02-17 2023-02-07 Springworks Therapeutics, Inc. Dispersible formulations of N-((R)-2,3-dihydroxypropoly)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide and uses thereof
WO2022195476A1 (en) 2021-03-15 2022-09-22 Clexio Biosciences Ltd. Gastroretentive devices for assessment of intragastric conditions

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4140755A (en) * 1976-02-13 1979-02-20 Hoffmann-La Roche Inc. Sustained release tablet formulations
EP0795324A2 (en) * 1996-02-19 1997-09-17 Jagotec Ag A pharmaceutical tablet characterized by a showing high volume increase when coming into contact with biological fluids
WO1999004764A1 (en) * 1997-07-23 1999-02-04 Perio Products Ltd. Tannic acid-polymer compositions for controlled release of pharmaceutical agents, particularly in the oral cavity

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4167558A (en) * 1976-02-13 1979-09-11 Hoffmann-La Roche Inc. Novel sustained release tablet formulations
US4434153A (en) * 1982-03-22 1984-02-28 Alza Corporation Drug delivery system comprising a reservoir containing a plurality of tiny pills

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4140755A (en) * 1976-02-13 1979-02-20 Hoffmann-La Roche Inc. Sustained release tablet formulations
EP0795324A2 (en) * 1996-02-19 1997-09-17 Jagotec Ag A pharmaceutical tablet characterized by a showing high volume increase when coming into contact with biological fluids
WO1999004764A1 (en) * 1997-07-23 1999-02-04 Perio Products Ltd. Tannic acid-polymer compositions for controlled release of pharmaceutical agents, particularly in the oral cavity

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO0200213A1 *

Also Published As

Publication number Publication date
KR20030013460A (ko) 2003-02-14
HUP0301465A2 (hu) 2004-05-28
EP1305021A1 (en) 2003-05-02
WO2002000213A1 (en) 2002-01-03
AU6872201A (en) 2002-01-08
MXPA02012793A (es) 2004-07-30
EA200300046A1 (ru) 2003-10-30
IL153497A0 (en) 2003-07-06
AU2001268722B2 (en) 2005-08-11
AU2001268722B8 (en) 2005-09-29
CZ2003199A3 (cs) 2003-12-17
JP2004501190A (ja) 2004-01-15
CA2412490A1 (en) 2002-01-03
HUP0301465A3 (en) 2006-07-28

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Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

17P Request for examination filed

Effective date: 20030121

AK Designated contracting states

Designated state(s): AT BE CH CY DE DK ES FI FR GB GR IE IT LI LU MC NL PT SE TR

AX Request for extension of the european patent

Extension state: AL LT LV MK RO SI

A4 Supplementary search report drawn up and despatched

Effective date: 20090825

17Q First examination report despatched

Effective date: 20100816

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE APPLICATION IS DEEMED TO BE WITHDRAWN

18D Application deemed to be withdrawn

Effective date: 20101228